A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
BeOne Medicines
Study ID
NCT07414836
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BG-C0979 — DRUG
    Administered by intravenous infusion.
  • Tislelizumab — DRUG
    Administered by intravenous infusion.

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).

Key Dates

Start date
Apr 13, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Monotherapy Dose Escalation
    Participants will receive increasing doses of BG-C0979 as monotherapy.
  • Experimental: Phase 1a: Monotherapy Safety Expansion
    Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion.
  • Experimental: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
    Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a.
  • Experimental: Phase 1b, Part B: Combination Therapy Expansion
    Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.

Primary Outcome Measure

Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
John Theurer Cancer Center Hackensack University Medical CenterHackensackNew Jersey07601-
Next Oncology San AntonioSan AntonioTexas78229-

Find similar trials in Hackensack, NJ

By research site
John Theurer Cancer Center Hackensack University Medical Center· Hackensack, NJNext Oncology San Antonio· San Antonio, TX

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